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2025-521762-99-00RecruitingPhase 3

Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants

Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants – a multicentre randomised placebo-controlled clinical trial

Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Sept 2026

Next steps

Brief summary (registry, in English)

To assess whether intravenous thrombolysis with tenecteplase 0.25 mg/kg improves functional outcome after acute ischemic stroke in patients taking direct oral anticoagulants compared to placebo.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
668 (estimated)
First submitted
1 Oct 2025
Start date
9 Mar 2026
Lead sponsor
University Medical Center Hamburg-Eppendorf
Diseases
Stroke
EU CT number
2025-521762-99-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 668
  • 42 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to intravenous thrombolysis, except DOAC therapy
  • Concomitant therapy with antithrombotic medications, except DOACs
  • Any anticipated surgical intervention within 12 hours

Other illness

  • Significant pre-stroke disability (mRS > 3)

Other

  • Reversal or planned reversal of anticoagulation with idarucizumab or andexanet alfa
  • Anticipated stenting of cervical or intracranial artery within 12 hours
  • Anticipated coronary angioplasty within 12 hours

Who the study is looking for

  • Age ≥ 18 years
  • Clinical diagnosis of acute stroke with disabling deficit
  • National Institutes of Health Stroke Scale (NIHSS) score at least 2
  • Recent intake (within 48 hours prior to enrolment) of a direct oral anticoagulant (apixaban, rivaroxaban, edoxaban, or dabigatran)
  • No evidence of any intracranial haemorrhage on cerebral imaging (CT or MRI) performed after stroke onset and no earlier than 60 minutes before enrolment
  • Stroke symptoms not known to have been present for > 6 h
  • For patients not known to have been awake and without acute stroke symptoms within 4.5 hours prior to enrolment, additional imaging criteria must be satisfied: a) If stroke symptoms are known to have been present for > 4.5 h (late time window): core/penumbra mismatch on MR or CT perfusion imaging; b) If stroke symptoms are not known to have been present for > 4.5 h (unknown time window): core/penumbra mismatch on MR or CT perfusion imaging; or DWI/FLAIR mismatch on MR imaging.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (42)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Aachen AöRAachenGermanyRecruiting
Klinikum Altenburger Land GmbHAltenburgGermanyRecruiting
Kamillus Klinik Asbach gGmbHAsbachGermanyRecruiting
Klinikum Aschaffenburg-Alzenau gGmbHAschaffenburgGermanyRecruiting
Universitaetsklinikum AugsburgAugsburgGermanyRecruiting
Charite Universitaetsmedizin Berlin KöRBerlinGermanyRecruiting
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbHBochumGermanyRecruiting
Universitaetsklinikum Bonn AöRBonnGermanyRecruiting
Gesundheit Nord gGmbH Klinikverbund BremenBremenGermanyRecruiting
Klinikum Chemnitz gGmbHChemnitzGermanyRecruiting
Klinikum Dortmund gGmbHDortmundGermanyRecruiting
Technische Universitaet DresdenDresdenGermanyRecruiting
Universitaetsklinikum Duesseldorf AöRDuesseldorfGermanyRecruiting
Universitaetsklinikum Erlangen AöRErlangenGermanyRecruiting
Klinikum Frankfurt Hoechst GmbHFrankfurt Am MainGermanyRecruiting
Martha-Maria Krankenhaus Halle-Doelau gGmbHHalle (saale)GermanyRecruiting
Asklepios Kliniken Hamburg GmbHHamburgGermanyRecruiting
University Medical Center Hamburg-EppendorfHamburgGermanyRecruiting
Medizinische Hochschule HannoverHanoverGermanyRecruiting
Katholische Hospitalvereinigung Weser-Egge gGmbHHoexterGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöRKielGermanyRecruiting
Universitaet LeipzigLeipzigGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöRLuebeckGermanyRecruiting
Staedtisches Klinikum Lueneburg gGmbHLueneburgGermanyRecruiting
Otto Von Guericke Universitaet MagdeburgMagdeburgGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainzGermanyRecruiting
Heidelberg UniversityMannheimGermanyRecruiting
Philipps-Universitaet MarburgMarburgGermanyRecruiting
Evangelisches Krankenhaus Mettmann GmbHMettmannGermanyRecruiting
Muehlenkreiskliniken AöRMindenGermanyRecruiting
Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbachGermanyRecruiting
Universitaet MuensterMuensterGermanyRecruiting
LMU Klinikum Muenchen AöRMunichGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)MunichGermanyRecruiting
Klinikum NuernbergNurembergGermanyRecruiting
Evangelische Krankenhausstiftung OldenburgOldenburgGermanyRecruiting
Klinikum Osnabrueck GmbHOsnabrueckGermanyRecruiting
Klinikum Ernst von Bergmann gGmbHPotsdamGermanyRecruiting
Universitaetsklinikum Regensburg AöRRegensburgGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgartGermanyRecruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbHWiesbadenGermanyRecruiting
Universitaetsklinikum Wuerzburg AöRWuerzburgGermanyRecruiting

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